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510(k) K831404

BLOOD MONITOR BMM 10-4 by Gambro, Inc. — Product Code LLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
May 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Blood, Extracorporeal And Accessories
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K890112 — ENGSTROM ELIZA + CO2 ANALYZER (March 15, 1989)

Other clearances for product code LLB

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